Mucosolvan solution for oral and inhalation. 15mg / 2ml vials 100ml Cap. with measured glass

Description

Composition
Active substance:
1 ml of solution contains: 7.5 mg of ambroxol hydrochloride.
Excipients:
Citric acid monohydrate 2 mg sodium dihydrogen phosphate dihydrate 4.35 mg Sodium chloride 6.22 mg benzalkonium chloride 225 g, purified water 989.705 mg.
Description:
Transparent, colorless or slightly brownish solution.
Product form:
Solution for oral and inhalation of 7.5 mg / ml. 100 ml amber glass vials with a polyethylene dropper and a polypropylene screw cap with tamper-evident. Each vial was placed in a cardboard box with instructions for use and a measured glass.
Contraindications
Hypersensitivity to ambroxol or other ingredients, pregnancy (I term), lactation.
Be wary of Mucosolvan® during pregnancy (II-III trimester), renal and / or liver failure.
Dosage
7.5 mg / ml
Indications
Acute and chronic respiratory disease with separation of viscous mucus: acute and chronic bronchitis, pneumonia, chronic obstructive pulmonary disease, bronchial asthma with difficulty sputum discharge, bronchiectasis.
Interaction with other drugs
Clinically significant, undesirable interactions with other drugs have not been reported. Increases penetration into the bronchial secretion of amoxicillin, cefuroxime, erythromycin.
Overdose
Specific symptoms of overdose in humans has not been described. There are reports of accidental overdose and / or medical error, which resulted in the observed symptoms known side effects Mucosolvan®: nausea, indigestion, vomiting, diarrhea, abdominal pain. In this case, the possible need for symptomatic therapy. Treatment: artificial vomiting, gastric lavage in the first 1-2 hours after ingestion, symptomatic therapy.
pharmachologic effect
Pharmacological group:
Expectorant, mucolytic agent.
Pharmacodynamics:
The studies have shown that Ambroxol – the active ingredient Lazolvana® – increases secretion in the airways. It enhances the production of pulmonary surfactant, and stimulates ciliary activity. These effects lead to increased transport current and mucus (mucociliary clearance). Strengthening improves mucociliary clearance of sputum expectoration and eases cough. In patients with chronic obstructive pulmonary disease Lazolvanom® prolonged therapy (for at least 2 months) resulted in a significant reduction in the number of exacerbations. There was a significant decrease in the duration of exacerbations and the number of days of antibiotic therapy.
Pharmacokinetics:
For all dosage forms immediate release ambroxol is characterized by rapid and nearly complete absorption from the linear dependence on the dose of the therapeutic concentration range. Maximum plasma concentration (Cmax) after oral administration is achieved by 1- 2.5 hours. The volume of distribution is 552 liters. In the therapeutic concentration range of plasma protein binding is approximately 90%. Going ambroxol from blood to tissues after oral administration is rapid. The highest concentration of active ingredient of the drug are observed in the lungs. Approximately 30% of the administered oral dose is exposed to the effect of first pass through the liver. Studies in human liver microsomes indicated that CYP3A4 is the predominant isoform responsible for the metabolism of ambroxol to dibromantranilovoy acid. The remainder of ambroxol is metabolized in the liver primarily by glucuronidation and by partial digestion to dibromantranilovoy acid (approximately 10% of the administered dose), and also a small amount of additional metabolites. The terminal half-life of ambroxol is 10 hours. The total clearance is in the range 660 ml / min for renal clearance accounting for about 8% of the total clearance. The method of radiolabel was estimated that, after receiving a one-time dose of the drug for a further 5 days with urine is released about 83% of the dose. Not detected clinically significant effect of age and gender on the pharmacokinetics of ambroxol, there is no reason for the selection of dosage on these grounds.
Pregnancy and breast-feeding
Ambroxol crosses the placental barrier. Preclinical studies revealed no direct or indirect adverse effects on pregnancy, embryonic / fetal, postnatal development and labor. Extensive clinical experience with ambroxol after the 28th week of pregnancy found no evidence of a negative effect of the drug on the fetus. However, you must observe the usual precautions when using the medication during pregnancy. Especially not recommended Mucosolvan® I trimester of pregnancy. In II and III trimester of pregnancy, the use of the drug is possible only if the potential benefit to the mother outweighs the potential risk to the fetus. Ambroxol is excreted in breast milk. Despite the fact that the undesirable effects in children receiving breast-feeding is not observed in the period of lactation is not recommended Mucosolvan® solution for oral and inhalation. Preclinical survey of the ambroxol showed no negative effects on fertility.
Conditions of supply of pharmacies
Without recipe.
side effects
Disorders of the gastrointestinal tract
Frequently (1.0 – 10.0%) – nausea, decrease in sensitivity in an oral cavity or pharynx;
Infrequently (0.1 – 1.0%) – dyspepsia, vomiting, diarrhea, abdominal pain, dry mouth;
Rarely (0.01 – 0.1%) – dry throat.
Immune system disorders, skin and subcutaneous tissue
Rarely (0.01 – 0.1%) – skin rash, urticaria; anaphylactic reactions (including anaphylactic shock), * * angioedema, pruritus * * hypersensitivity.
Disorders of the nervous system
Frequently (1.0 – 10.0%) – dysgeusia (taste disturbance). * – data adverse reactions observed with the broad application of the drug; 95% probability of data frequency of adverse reactions – rarely (0.1% -1.0%), but it is possible and below; the exact frequency is difficult to estimate, since they were not seen in clinical trials.
special instructions
It should not be combined with antitussive agents that prevent removal of sputum. Preservative solution contains benzalkonium chloride which when inhaled can cause bronchospasm in sensitized patients with increased airway reactivity. Mucosolvan® solution for oral and inhalation is not recommended to mix with cromoglicic acid and alkaline solutions. Increasing the pH of the solution above 6.3 can cause precipitation of ambroxol hydrochloride or the appearance of opalescence. Patients who observe giponatrievuyu diet, must be taken into account that Mucosolvan® solution for oral and inhalation contains 42.8 mg sodium in the recommended daily dose (12 ml) for adults and children over 12 years. There are few reports of severe skin lesions such as Stevens-Johnson syndrome and toxic epidermal necrolysis, which coincided with the appointment expectorant drugs such as ambroxol hydrochloride. In most cases, they can be explained by the severity of the underlying disease and / or concomitant therapy. In patients with Stevens-Johnson syndrome or toxic epidermal necrolysis in the early phase may appear fever, body pain, rhinitis, cough and sore throat. The symptomatic treatment of cough and possibly erroneous assignment of funds. When new skin lesions and mucous membranes is recommended to discontinue treatment ambroxol and immediately seek medical attention. If the kidney function Mucosolvan® should be used only under medical recommendation.
Effect of the drug on the ability to drive mechanisms and
There were no cases of the influence of the drug on the ability to drive and use machines. Studies on the effect of the drug on the ability to drive and engage in other potentially hazardous activities that require high concentration and psychomotor speed reactions were not carried out.
Storage conditions
Store at a temperature not higher than 25 C in its original packaging.
Keep out of the reach of children.
Dosing and Administration
inside
Ingestion (1 ml = 25 drops). Adults and children over 12 years: 4 ml (= 100 drops) three times a day; Children 6 to 12 years: 2 ml (= 50 drops) 2-3 times a day; Babies from 2 to 6: 1 ml (= 25 drops) three times a day; Children under 2 years of age: 1 ml (= 25 drops), 2 times a day. The drops can be diluted in water, tea, juice or milk. Apply the solution can be independent of food intake.
inhalation
Adults and children over 6 years: 1-2 inhalations 2-3 ml per day. Children aged 6: 1-2 inhalation of 2 ml per day.
Mucosolvan® for inhalation solution can be applied using any equipment for inhalation (excluding steam inhaler). To achieve maximum wetting when inhaled drug mixed with 0.9% solution of sodium chloride in a ratio of 1: 1. Since the deep breath inhalation therapy may provoke cough, inhalation should be performed in a conventional mode of respiration. Before inhalation usually recommended to heat the inhalation solution to body temperature. Patients with asthma are recommended inhaled bronchodilator drug after ingestion, to avoid nonspecific stimuli and airway spasm.
In the case of preservation of symptoms within 4-5 days from the start of the reception it is recommended to consult a doctor.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist